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Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hy...

FDA Recall #D-1323-2022 — Class II — June 29, 2022

Recall #D-1323-2022 Date: June 29, 2022 Classification: Class II Status: Terminated

Product Description

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

Reason for Recall

CGMP Deviations: products were stored outside the drug label specifications.

Recalling Firm

Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

113 bottles

Distribution

Nationwide in the USA.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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